Phase 1 Study of XAF5 Gel Applied to Skin of Healthy Volunteers

Topokine Therapeutics

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Placebo; Drug: XAF5, concentration C; Drug: XAF5, concentration A; Drug: XAF5, concentration B

Study type: Interventional

Funder types: Industry

Identifiers

NCT01723241

XAF5 A1

Details and patient eligibility

About

This is a study to assess the safety, tolerability, and pharmacokinetics of XAF5 Gel when applied to the skin of healthy volunteers.

Enrollment: 32 patients

Sex: All

Ages: 25 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy volunteers
• Must understand and provide informed consent
• Skin upon which a reaction would be visible
• Body weight >= 70 kg

Exclusion criteria

• Any active skin disease
• History of skin hypersensitivity
• Clinically significant abnormality on physical exam, ECG, or laboratory tests
• Positive test for HIV, Hepatitis B, or Hepatitis C

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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32 participants in 2 patient groups, including a placebo group

XAF5

Experimental group

Treatment:

Drug: XAF5, concentration B

Drug: XAF5, concentration C

Drug: XAF5, concentration A

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo